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P378. Safety of adalimumab in global clinical trials of ulcerative colitis patients

J.-F. Colombel1, S. Ghosh2, W. Sandborn3, G. Van Assche4, W. Reinisch5, A. Lazar6, S. Eichner7, B. Huang7, A. Robinson7, R. Thakkar7, 1Centre Hospitalier Universitaire de Lille, Lille, France, 2University of Calgary, Calgary, Canada, 3University of California San Diego, La Jolla, United States, 4University of Toronto, Toronto, Canada, 5Medical University Vienna, Vienna, Austria, 6AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, 7Abbott Laboratories, Abbott Park, United States


The safety profile of adalimumab (ADA) has been previously reported for the double-blind (DB) pivotal trials ULTRA 1 and ULTRA 2 in patients (pts) with moderate to severe ulcerative colitis (UC) [1,2]. Safety data from the ongoing open-label extension (OLE) continue to be collected.


All patients participating in ULTRA 1, ULTRA 2, and OLE had regular safety evaluations. Rates of adverse events (AEs) of interest were assessed per 100 patient-years (PY) of exposure. Event rates were calculated for placebo (PBO) and ADA during the DB period (up to week 52) from ULTRA 1 (160/80 mg dose group only) and ULTRA 2 and through 15 Apr 2012 for any ADA exposure (ULTRA 1, ULTRA 2, or the OLE).


As of 15 Apr 2012, 1010 pts had received ADA for UC, totaling 2007.4 PY of exposure. AE rates observed during DB treatment and up to the 15 April 2012 update are shown (Table). A similar overall rate of AEs was observed during DB treatment between PBO and ADA. Serious AEs, serious infections, AEs leading to discontinuation, and UC worsening/flare were more frequent with PBO, whereas opportunistic infections, injection site reactions, and hepatic events were more frequent with ADA. AE rates during any ADA exposure were consistent with rates previously reported for ADA and other anti-TNFs in CD [3,4].

Table: Treatment-emergent AEs
 DB exposure up to
Wk 52
Exposure as of 15 April 2012
N = 483
PY = 153
E (E/100PY)
ADA (160/80 mg)
N = 480
PY = 179
E (E/100PY)
N = 1010
PY = 2007
E (E/100PY)
Any AE1316 (860.9)1410 (787.9)7508 (374.0)
Serious AE69 (45.1)54 (30.2)374 (18.6)
AE leading to discontinuation62 (40.6)39 (21.8)235 (11.7)
Serious infection10 (6.5)4 (2.2)68 (3.4)
Opportunistic infectiona (excluding TB)3 (2.0)7 (3.9)29 (1.4)
Tuberculosis001 (<0.1)
Injection site reaction25 (16.4)84 (46.9)241 (12.0)
Any malignancy2 (1.3)2 (1.1)21 (1.0)
Lymphoma003 (0.15)
Congestive heart failure01 (0.56)3 (0.15)
Demyelinating disease002 (0.1)
Hepatic event12 (7.9)23 (12.9)89 (4.4)
UC worsening/flare106 (69.3)82 (45.8)553 (27.5)
Death002 (0.1)
AE = adverse events; E = events; PY = patient-years.
aMostly candidiasis.


The safety profile and AE rates observed with long-term ADA exposure (up to 4 yrs) in UC were similar to those occurring during DB therapy. No new safety signals were identified.

1. Reinisch, et al. 2011. Gut 60: 780.

2. Sandborn, et al. 2012. Gastroenterology 142: 257.

3. Colombel, et al. 2009. Inflamm Bowel Dis 5: 1308.

4. Lichtenstein, et al. 2012. Am J Gastroenterol 107: 1409.